Home >> Top News >> FDA clears Hologic’s M. genitalium assay 

FDA clears Hologic’s M. genitalium assay 

Print Friendly, PDF & Email

Jan. 30, 2019—Hologic announced that the U.S. Food and Drug Administration has granted clearance for its Aptima Mycoplasma genitalium assay through the FDA’s de novo request process. This is the first test authorized by the FDA to test for M. genitalium, which is associated with nongonococcal urethritis in men and cervicitis and pelvic inflammatory disease in women.

“Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems,” Damon Getman, PhD, senior principal research scientist and director of research at Hologic, said in a press release. “The introduction of the Aptima Mycoplasma genitalium assay gives health care professionals the opportunity to provide optimal care for their patients and reflects Hologic’s commitment to developing innovative solutions that address emerging public health threats.”


Check Also

Health Canada approves Panther Fusion

August 2018—Hologic has obtained approval from Health Canada for its Panther Fusion system and Panther Fusion assays for respiratory virus infections. The Panther Fusion module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the company’s Aptima brand.